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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT Back to Search Results
Catalog Number 61910002
Device Problem Use of Device Problem (1670)
Patient Problem Paralysis (1997)
Event Date 03/25/2019
Event Type  Injury  
Manufacturer Narrative
The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that screw replacement and cement fixation for screw loosening after lumbar posterior fixation.A laminectomy was done due to cement leakage into the spinal canal at after operation x-p.The surgeon found paralysis of the right lower extremity after operation.Currently, the patient are doing rehabilitation for nerve palsies.
 
Manufacturer Narrative
An event regarding user error involving simplex p cement mix was reported.Conclusion: a review of the device manufacturing records could not be completed as the lot number is unknown.Therefore, it could not be determined the revision of the ifu packaged with the device at the time of manufacture.A review of the most recent version of the ifu relating to part number 61910002, ifu 0700-7-006 version ab, noted the following:  [intended use of effect] 1.Purpose of the product this product is meant for use in joint replacement surgery for filling between the prosthesis (endprothesis, total hip arthroplasty, total knee arthroplasty, etc.) and the part where it is implanted, for fixing the prosthesis and substituting for any defects.2.Indications for fixing of an implant to the bone in arthroplasty undertaken to correct the following diseases and symptoms: osteoarthritis, rheumatoid arthritis, osteonecrosis, sickle cell anemia, collagen disease, and severe joint destruction secondary to trauma or other conditions.It was reported that screw replacement and cement fixation on (b)(6)2019 for screw loosening after lumbar posterior fixation.A laminectomy was done due to cement leakage into the spinal canal at after operation x-p.The surgeon found paralysis of the right lower extremity after operation.Currently, the patient are doing rehabilitation for nerve palsies.No further information was provided.Based on the investigation, the simplex p product is intended for use in joint replacement surgery but it was used for spinal surgery in this event.Based on the provided information it has been determined that this event is associated with an off-label application.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that screw replacement and cement fixation for screw loosening after lumbar posterior fixation.A laminectomy was done due to cement leakage into the spinal canal at after operation x-p.The surgeon found paralysis of the right lower extremity after operation.Currently, the patient are doing rehabilitation for nerve palsies.
 
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Brand Name
SIMPLEX P-JAPANESE TWIN PACK
Type of Device
BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8616837
MDR Text Key145278008
Report Number0002249697-2019-01962
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number61910002
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age70 YR
Patient Weight48
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